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Paraplegia, SpinalHIITNCT04378218

Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia

A study testing High Intensity Interval Training (HIIT) in people with Paraplegia, Spinal and Spinal Cord Trauma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study seeks to determine whether high intensity interval training has an effect on cardiovascular parameters in wheelchair users with paraplegia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Paraplegia, Spinal, Spinal Cord Trauma
What is being tested?
High Intensity Interval Training (HIIT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
12 Dec 2019to 16 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Spinal cord injury located at or below the seventh thoracic vertebrae
  • Manual wheelchair user (primary means of mobility)At least 6 months post-SCI
  • At least 18 years of age
  • Able to perform a high-intensity exercise program
  • Willingness to participate in 16 weeks of an exercise program
  • Personal cell phone with the ability to run the Polar Beat application and BlueTooth capabilities

Who cannot join

  • Spinal cord injury at or above the sixth thoracic vertebrae
  • Manual wheelchair is not the primary means of mobility (ex. community ambulators, power wheelchair users)
  • Any documented or reported health condition that would be contraindicated to a progressive exercise program (active upper limb musculoskeletal injuries, autonomic instability, unstable cardiopulmonary disease such as unstable angina, COPD, etc., or pregnancy).
  • Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

The study seeks to determine whether high intensity interval training has an effect on cardiovascular parameters in wheelchair users with paraplegia.

Read the detailed description

The objective of this pilot study is to produce preliminary data testing the feasibility and effectiveness of high intensity interval training (HIIT) on cardiovascular health parameters in individuals with paraplegia. The long term research goal is to determine whether these short term physiologic effects translate to long term reduction in cardiovascular disease and mortality in this high risk population. The rationale for this study is that identifying a well-accepted form of exercise in individuals with paraplegia, which is safe and effective in improving cardiovascular health parameters, would provide an efficient and sustainable evidence-based approach to lowering cardiovascular disease risk. We propose the following two Specific Aims:

Specific Aim #1: Measure cardiovascular changes after a 16-week HIIT program in individuals with paraplegia. Measurements will include oxygen utilization during maximal exercise via VO2max testing (primary outcome measure), body composition via dual energy X-ray absorptiometry, blood lipid panel, C-reactive protein blood test, and glucose utilization via oral glucose tolerance blood test.

Specific Aim #2: Investigate the feasibility, sustainability and acceptance of implementing high-intensity interval training (HIIT) via arm-ergometer as a form of home exercise in individuals with paraplegia. After the personalized training session with the arm-ergometer and the HIIT protocol, each participant will be given an arm-ergometer (also known as arm-cycle) to use within their home to complete three sessions weekly for the entire16 week program. An adjustable table will be provided to allow for height customization of each arm-ergometer, and provide a method for securing the device during exercise. The arm-ergometers allow the subject to complete the exercise intervention from their own wheelchair. Compliance will be monitored via chest strap heart rate monitors. Acceptance of the program will be determined through a pre- and post- training survey Spinal Cord Injury Exercise Self-Efficacy Scale (SCI ESES) and interview with participants.

At the completion of this project, we expect to have determined whether HIIT is an appropriate form of exercise intervention for individuals with paraplegia, effective in improving short-term cardiovascular health parameters within a 16 week home program. We anticipate participants will find HIIT acceptable given the time-efficiency of the protocol, the convenience of using their own wheelchair and the elimination of environmental barriers by performing the program within their home. This study is expected to have a positive impact on cardiovascular health in individuals with paraplegia and foresee this form of exercise being implemented as a standard of care recommendation in the physical activity guidelines for individuals with paraplegia.

Being tested
High Intensity Interval Training (HIIT)
Keywords
HIIT
Medical subject headings
Paraplegia, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Interval Training (HIIT)Behavioural

    A 16 week, 3 sessions per week HIIT program from the subject's personal wheelchair, positioned near an adjustable table with an arm-ergometer affixed.

Study groups in NCT04378218
Study groupRoleWhat they receive
HIIT InterventionExperimentalNot described
Receives: Behavioral: High Intensity Interval Training (HIIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical activity

    Change in physical activity, as measured by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) survey

    Measured: Baseline, Week 8, Week 16

  2. Exercise self-efficacy

    Change in exercise self-efficacy, as measured by the SCI Exercise Self-Efficacy Scale (SCI ESES), with changes in individual responses rated as more true indicating more efficacy.

    Measured: Baseline, Week 8, Week 16

  3. Glucose metabolism

    Changes in metabolism of glucose, as measured by a 120 minute oral glucose tolerance test (OGTT), with lower glucose values indicating more efficient metabolism.

    Measured: Baseline, Week 8, Week 16

  4. Inflammatory marker

    Changes in measurements of proteins representing inflammatory processes via the C-Reactive Protein blood test, with lower values indicating a state of less cardiovascular risk.

    Measured: Baseline, Week 8, Week 16

  5. Lipid profile

    Changes in measurements of total cholesterol, triglycerides, HDL, calculated LDL, and non-HDL cholesterol, with lower values (excepting HDL) indicating lower cardiovascular risk.

    Measured: Baseline, Week 8, Week 16

  6. Oxygen metabolism

    Changes in metabolism of oxygen, as measured by the Graded Exercise Test (GXT), also known as the VO2 Maximum Test, with higher O2 intake values indicating higher aerobic capacity.

    Measured: Baseline, Week 8, Week 16

  7. Bone mineral density

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in bone mineral content and bone density.

    Measured: Baseline, Week 8, Week 16

  8. Body composition - body fat mass

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total body fat mass.

    Measured: Baseline, Week 8, Week 16

  9. Body composition - lean mass

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total lean mass.

    Measured: Baseline, Week 8, Week 16

  10. Body composition - android and gynoid fat percentage

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android and gynoid fat percentage.

    Measured: Baseline, Week 8, Week 16

  11. Body composition - android and gynoid fat ratio

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total android to gynoid fat ratio.

    Measured: Baseline, Week 8, Week 16

  12. Body composition - bone mass

    Measurement by dual-energy x-ray absorptiometry (DXA) of change in regional and total bone mass.

    Measured: Baseline, Week 8, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start12 Dec 2019
  3. Primary completion16 Jul 2021
  4. Study completion16 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Pre-post trial, observational, feasibility study
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04378218
Sponsor's protocol ID
18-004972
Acronym
HIIT
Status last verified
Aug 2021
First submitted
7 Nov 2019
Last updated
20 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training (HIIT) in people with Paraplegia, Spinal and Spinal Cord Trauma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity (time frame: Baseline, Week 8, Week 16). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04378218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.

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